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Clinical Trial Details

Trial ID: L2912
Source ID: NCT05689372
Associated Drug: Semaglutide
Title: Regulatory Post Marketing Surveillance (rPMS) Study of Ozempic (Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide
Outcome Measures: Primary: Number (incidence) of adverse events (AEs), Measured as count of events., From baseline (week 0) to 26 weeks | Secondary: Number (incidence) of hypoglycaemia level 3 or level 2 according to American Diabetes Association (ADA) guideline 2020, Measured as count of events. Level 2 refers to glucose less than (\<) 54 milligrams per deciliter (mg/dL) (3.0 millimoles per liter \[mmol/L\]). Level 3 refers to a severe event characterized by altered mental and/or physical status requiring assistance for treatment of hypoglycaemia., From baseline (week 0) to 26 weeks|Change in glycated haemoglobin (HbA1c), Measured in percentage., From baseline (week 0) to 26 weeks|Participants achieving HbA1c target < 7.0 percent (%), Measured as count of participants., At 26 weeks|Change in fasting blood glucose (FBG)/fasting plasma glucose (FPG), Measured in milligrams per deciliter (mg/dl)., From baseline (week 0) to 26 weeks|Change in post prandial blood glucose (PPBG)/post prandial plasma glucose (PPPG), Measured in mg/dl., From baseline (week 0) to 26 weeks|Change in body weight, Measured in kilogram (kg)., From baseline (week 0) to 26 weeks|Dose of Ozempic, Measured in milligrams per day (mg/day)., At 26 weeks
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 600
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2025-03-31
Completion Date: 2026-11-30
Results First Posted:
Last Update Posted: 2024-09-19
Locations:
URL: https://clinicaltrials.gov/show/NCT05689372